Wearable Focused Ultrasound Stimulation for Peripheral Nerve Pain Management

Summary

This study will evaluate the feasibility of a novel wearable focused ultrasound (FUS) device for peripheral nerve stimulation in healthy volunteers. The aim is to assess device operability, usability, tolerability, and physiological responses during standardized sensory tests. Each participant will complete nine \~1-hour study sessions across multiple days, including cold pressor and algometry tasks performed under baseline, sham, and active FUS conditions.

Conditions

• Pain Management
• Peripheral Neuropathic Pain

Interventions

DEVICE

Cold Pressor Task - Upper Limb

This study uses a three-session cold pressor paradigm to evaluate feasibility of a wearable focused ultrasound (FUS) device for peripheral nerve stimulation. Session 1 (Baseline): After consent, participants immerse the dominant hand in 0-1 °C water (\~10 cm depth) in an insulated bucket. Time to first pain is recorded, with 5 min rests between immersions (12 total; max single immersion 6 min). Water temperature is digitally monitored, with ice added as needed. Session 2 (Sham): The median/ulnar/radial nerve in the dominant forearm is located by ultrasound. The FUS device is applied with hydrogel but set to sham (no output). The cold pressor protocol is repeated. Session 3 (Active FUS): After nerve localization, active FUS (650 kHz, 60-100% intensity, 20-30% duty cycle) is delivered for 5 min. The cold pressor test is repeated to record pain tolerance as an exploratory physiological response during feasibility testing.

DEVICE

Algometry Pain Tests in the Upper Limb

This session records pressure pain thresholds in the dominant hand with a wearable FUS device and a pressure algometer during feasibility testing. Session 1 (Baseline): After consent and briefing, the median, ulnar, and radial nerves at three points on the dominant hand (wrist, palm, finger) are located via ultrasound and marked. A pressure algometer is applied to each site, with pressure gradually increased until pain is first reported. Thresholds are recorded, with each location tested three times with short breaks. Session 2 (Sham): The same nerve sites are identified and marked. The wearable FUS device is applied with hydrogel but set to sham (no active output). The baseline algometry protocol is repeated. Session 3 (Active FUS): Following nerve localization, active FUS (650 kHz, 60-100% intensity, 20-30% duty cycle) is delivered for 5 min. The algometry test is repeated to record pressure pain thresholds as exploratory physiological responses during feasibility testing.

DEVICE

Algometry Pain Tests in the Lower Limb

This session records pressure pain thresholds in the dominant foot with a wearable FUS device and a pressure algometer during feasibility testing. Session 1 (Baseline): After consent and briefing, the tibial, saphenous, and peroneal nerves at three standardized points on the dominant foot are located via ultrasound and marked. A pressure algometer is applied to each site, and pressure is gradually increased until pain is first reported. Thresholds are recorded, with repeated trials and short breaks between tests. Session 2 (Sham): The same nerve sites are identified and marked. The wearable FUS device is applied with hydrogel but set to sham (no active output). The baseline algometry protocol is repeated. Session 3 (Active FUS): Following nerve localization, active FUS (650 kHz, 60-100% intensity, 20-30% duty cycle) is delivered for 5 min. The algometry test is then repeated to record pressure pain thresholds as exploratory physiological responses during feasibility testing.

Sponsors & Collaborators

• University of Texas at Austin

  lead OTHER

Principal Investigators

• Huiliang Wang, PhD · University of Texas at Austin

Study Design

Allocation

NON_RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

20 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-07-14

Primary Completion

2025-09-15

Completion

2025-10-15

FDA Device

Yes

Countries

• United States

Study Locations